A Study for the Neoadjuvant Treatment of Breast Cancer

June 28, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

A Prospective, Open-label Study to Evaluate Injectable Albumin-bound Paclitaxel Versus Docetaxel for the Neoadjuvant Treatment of Breast Cancer

Due to the unique advantages of albumin-bound paclitaxel, several studies in China and abroad have tried to use albumin-bound paclitaxel for neoadjuvant treatment of breast cancer up to now. However, comparative studies between paclitaxel and docetaxel are still rare, In this study, a prospective, randomized, open-label, multi-center clinical study was conducted to analyse the efficacy and safety of albumin-bound paclitaxel and docetaxel in the neoadjuvant treatment of breast cancer, and to further analyse the efficacy and safety of albumin paclitaxel in combination with chemotherapy for postoperative breast cancer in different subtypes of breast cancer patients, in order to obtain more realistic data and provide new treatment options for breast cancer patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Neoadjuvant chemotherapy refers to systemic chemotherapy as the first step for treating breast cancer patients before planned local treatment like surgery for those without distant metastasis. It is reported that preoperative neoadjuvant chemotherapy can facilitate breast conservation, render inoperable tumors operable and provide important prognostic information at an individual patient level based on response to therapy.

Previous studies have confirmed that the efficacy of albumin-bound paclitaxel in neoadjuvant therapy and was well tolerated when combined with sequential chemotherapy with anthracyclines .

The GBG69 study was the first to compare the efficacy and safety of nab-paclitaxel (nab-P) and solvent-based paclitaxel in the neoadjuvant treatment of breast cancer. The results showed that the pCR rate in the nab-P group was significantly higher than that in the solvent paclitaxel group (38% vs 29% p<0.001). Long-term follow-up results showed that after 4 years, iDFS was also significantly improved in nab-P-treated patients compared with solvent paclitaxel (84.0% vs 76.3%; HR, 0.66; 95% CI, 0.51-0.86; P = 0.0023).

Another phase II study compared docetaxel and albumin paclitaxel in neoadjuvant chemotherapy for HER2-negative early-stage breast cancer. The results showed a slightly higher pCR rate in the nab-P group (docetaxel: 12%; nab-P: 17%). In the Ki67>20% subgroup, the pCR rates were 16% (docetaxel) vs 24% (nab-P) respectively. demonstrating that albumin-bound paclitaxel (nab-P) appears to demonstrate greater efficacy in breast cancer compared to docetaxel.

However, comparative studies between paclitaxel and docetaxel are still rare, In this study, a prospective, randomized, open-label, multi-center clinical study was conducted to analyse the efficacy and safety of albumin-bound paclitaxel and docetaxel in the neoadjuvant treatment of breast cancer, and to further analyse the efficacy and safety of albumin paclitaxel in combination with chemotherapy for postoperative breast cancer in different subtypes of breast cancer patients, in order to obtain more realistic data and provide new treatment options for breast cancer patients.

Study Type

Interventional

Enrollment (Anticipated)

1576

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female patients aged ≥18 years;
  2. unilateral primary invasive breast cancer that meets clinical diagnostic criteria and is histologically confirmed;
  3. The tumor is >2cm, and the clinical stage is consistent with cT stage 2-4; or lymph node metastasis with clear clinical/pathological evidence;
  4. known hormone receptor status (estrogen receptor [ER], progesterone receptor [PR]) and HER2 status with known Ki67 expression levels; (ER/PR positive defined as stained cells >1%, HER2 positive defined as IHC 3+ or IHC 2+ with a positive FISH test);
  5. Triple-negative breast cancer (TNBC): ER/PR negative, HER2 negative; tumor >2cm or lymph node metastasis with clear postoperative pathological evidence; Luminal breast cancer: ER>1%, HER2 negative, postoperative pathological evidence definite lymph node metastasis (different adjuvant chemotherapy regimens depending on whether the lymph nodes are N1 or N2-3); HER2-positive breast cancer: HER2-positive, regardless of ER/PR status; (the above classification determines enrollment and neoadjuvant therapy, and does not represent the corresponding molecular typing definition);
  6. patients who need neoadjuvant chemotherapy as judged by the investigator;
  7. ECOG physical fitness score of 0-1;
  8. The patient has not received any treatment for breast cancer before enrollment;
  9. Electrocardiogram (ECG) and echocardiography must confirm normal cardiac function within 3 months prior to randomization. Left ventricular ejection fraction (LVEF) must be ≥55%;
  10. Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal; AST and ALT ≤3 times the upper limit of normal; total bilirubin ≤1.5 times the upper limit of normal, or ≤2.5 times the upper limit of normal when the patient has Gilbert's syndrome ;
  11. Bone marrow function: neutrophils≥1.5×109/L, platelets≥100×109/L, hemoglobin≥90g/L;
  12. Able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits during the study period;
  13. Subjects have the ability to understand, agree and sign the Informed Consent Form (ICF) for the study prior to initiating any protocol-related procedures; subjects have the ability to express consent (where applicable).

Exclusion Criteria:

  1. Advanced and/or inoperable patients with distant metastasis confirmed by imaging evidence or pathology;
  2. Patients with bilateral invasive breast cancer;
  3. Other malignant tumors have occurred in the past 5 years, except for skin cancers of cured cervical carcinoma in situ and non-melanoma;
  4. Pregnant or breastfeeding women; patients with childbearing potential who are unwilling or unable to take effective contraceptive measures;
  5. The molecular status of ER/PR and HER2 and Ki67 cannot be determined;
  6. Patients with CNS metastases or > grade 1 peripheral neuropathy;
  7. Surgical axillary staging within 6 months prior to study entry;
  8. Radiotherapy, chemotherapy, biotherapy and/or endocrine therapy for currently diagnosed breast cancer prior to study entry;
  9. Patients with severe myelosuppression at screening;
  10. Patients with severe liver dysfunction (Child's Class III) or renal dysfunction at screening ;
  11. Other concomitant diseases (e.g. untreated congenital heart disease, glomerulonephritis, etc.) which, in the opinion of the investigator, seriously endanger the safety of the patient or would prevent the implementation or completion of the programme treatment;
  12. Patients with hypersensitivity to any of the components of albumin paclitaxel, epirubicin, cyclophosphamide, docetaxel, trastuzumab, and pertuzumab;
  13. Patients with psychiatric disorders;
  14. Subjects who are participating in another clinical study or whose first dose was administered less than 4 weeks (or 5 half-lives of the study drug) from the end of the previous clinical study (last dose) ;
  15. The investigator judges other situations that may affect the clinical research and the judgment of the research results and are not suitable for inclusion in the research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: TCbHP
HER2-positive breast cancer
Drug: Docetaxel
75 mg/m2, d1, q3w,6 cycles
Drug: Carboplatin
AUC 6, d1, q3w ,6 cycles
Drug: Trastuzumab
starting dose 8 mg/kg, maintenance dose 6 mg/kg, d1, q3w ,6 cycles
Drug: Pertuzumab
starting dose of 840 mg, maintenance dose of 420 mg, d1, q3w,6 cycles
Drug: Docetaxel
100 mg/m2, d1, q3w × 4 cycles
EXPERIMENTAL: nPCbHP
HER2-positive breast cancer
Drug: Carboplatin
AUC 6, d1, q3w ,6 cycles
Drug: Trastuzumab
starting dose 8 mg/kg, maintenance dose 6 mg/kg, d1, q3w ,6 cycles
Drug: Pertuzumab
starting dose of 840 mg, maintenance dose of 420 mg, d1, q3w,6 cycles
Drug: Nab paclitaxel
220 mg/m2, d1, q3w,6 cycles
Drug: Nab paclitaxel
125 mg/m2, d1,8,15, q3w× 4 cycles
ACTIVE_COMPARATOR: EC-T
Luminal breast cancer (HER2-, LN+), and triple negative breast cancer
Drug: Docetaxel
75 mg/m2, d1, q3w,6 cycles
Drug: Docetaxel
100 mg/m2, d1, q3w × 4 cycles
Drug: Epirubicin
90 mg/m2,d1, q3w × 4 cycles,followed by docetaxel
Drug: Cyclophosphamide
600 mg/m2, d1, q3w ,4 cycles,followed by docetaxel
Drug: Epirubicin
90 mg/m2,d1, q2w × 4 cycles,followed by nab-paclitaxel
Drug: Cyclophosphamide
600 mg/m2, d1, q2w × 4 cycles followed by nab-paclitaxel
EXPERIMENTAL: ddEC-wnP
Luminal breast cancer (HER2-, LN+), and triple negative breast cancer
Drug: Nab paclitaxel
220 mg/m2, d1, q3w,6 cycles
Drug: Nab paclitaxel
125 mg/m2, d1,8,15, q3w× 4 cycles
Drug: Epirubicin
90 mg/m2,d1, q3w × 4 cycles,followed by docetaxel
Drug: Cyclophosphamide
600 mg/m2, d1, q3w ,4 cycles,followed by docetaxel
Drug: Epirubicin
90 mg/m2,d1, q2w × 4 cycles,followed by nab-paclitaxel
Drug: Cyclophosphamide
600 mg/m2, d1, q2w × 4 cycles followed by nab-paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pCR(pathological complete response)
Time Frame: 1year
defined as ypT0/is, ypN0 (defined as no invasive tumor in breast and axillary lymph nodes
1year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 10 years
overall survival
10 years
DFS
Time Frame: 2 years
disease-free survival
2 years
DMFS
Time Frame: 2 years
distant metastasis-free survival
2 years
Secondary pCR
Time Frame: 1 year
defined as ypT0, ypN0 (no invasive or residual carcinoma in situ lesions in breast and axillary lymph nodes
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 1year
tumor response rate based on imaging assessment in the neoadjuvant therapy (preoperative) stage
1year
Remission rate of neurotoxicity
Time Frame: 5 years
5 years
The incidence of other AEs
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 10, 2022

Primary Completion (ANTICIPATED)

June 10, 2027

Study Completion (ANTICIPATED)

December 20, 2027

Study Registration Dates

First Submitted

June 12, 2022

First Submitted That Met QC Criteria

June 12, 2022

First Posted (ACTUAL)

June 15, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 1, 2022

Last Update Submitted That Met QC Criteria

June 28, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0055

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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